Page 191«..1020..190191192193..200210..»

5 FDA decisions to watch in the fourth quarter – BioPharma Dive

Posted: October 4, 2022 at 1:42 am

Though 2022 has been a down year for the biotechnology sector, notable decisions from the Food and Drug Administration have provided a few bright spots.

Two gene therapies came to market, providing a lift for a field thats been slowed by recent setbacks. The cancer drug Enhertu was approved for a newly defined tumor type known as HER2-low. The regulator also cleared a new medicine for ALS and a first-of-its-kind inflammatory disease drug.

The fourth quarter could yield some other medical milestones. An Alzheimers drug that unexpectedly succeeded in a large trial last week is under review. So are what could be the first treatment for a common form of vision loss, a closely watched HIV drug, and a type of anemia pill the FDA has already turned back twice.

Here are 5 FDA decisions to watch:

In the decade since the FDA made Makena available for the prevention of preterm births, the treatment has become a flashpoint in the debate over speedy drug approvals.

Makena was developed by AMAG Pharmaceuticals and granted accelerated approval in 2011 based on a study showing it reduced the risk of preterm births which can jeopardize a babys health in women with a history of delivering early.

A study meant to confirm Makenas benefits took years to complete, however. When the results did arrive in 2019, Makena didnt perform meaningfully better than a placebo.

Since then, the fate of Makena has been the subject of a fight between the FDA, AMAG and the drugs current owner, Covis Pharma, which acquired AMAG in 2020. After an FDA advisory panel in 2019 recommended the regulator pull Makena from the market, the agency proposed doing so, arguing the available evidence does not show Makena is effective for its approved use.

Its developers, as well as some patient advocates and outside experts, have countered that doing so would be a mistake, claiming the drug still may help Black women at high risk of early births, who made up a larger portion of participants in the original trial than the confirmatory study.

A hearing on the issue has been delayed several times amid legal wrangling, extending the drugs time on market while its benefit remains unclear. The FDA specifically cited the case as an example of how lengthy and burdensome the withdrawal process may be when a company disagrees with the agency, according to a report on accelerated approvals published last week by the U.S. Department of Health and Human Services.

The back-and-forth could come to a conclusion this quarter. A three-day hearing of an FDA advisory panel will begin on Oct. 17 and feature discussions on the available confirmatory evidence as well as whether FDA should allow Makena to remain on the market.

GSKs daprodustat is the third anemia drug of its kind to be reviewed by the FDA. If the rejections of the first two are any indication, daprodustat could have a tough time when the agencys expert advisers meet to review it on Oct. 26.

Daprodustat is intended to be an oral alternative to injectable biologics like Epogen and Aranesp that boost red blood cell production and are used to treat anemia in patients with damaged kidneys. Those medicines have been standard treatments for years, but their use has been restricted because of the risk of heart problems.

GSKs drug is also meant to increase red blood cell levels, but by tricking the body into thinking its in a low-oxygen environment. The approach is meant to be both safer and more convenient for patients, and has spawned daprodustat as well as drugs from FibroGen and Akebia Therapeutics. All three are approved in Japan, and FibroGens is cleared for use in Europe.

But none are available in the U.S., where regulators have taken a tougher stance. In a meeting last year, the FDA and its expert reviewers challenged claims that FibroGens drug is safer than its injectable competitors. The agency rejected that medicine and demanded another trial. It then did the same to Akebias treatment in March.

GSK believes it has a better case. Unlike its rivals, daprodustat didnt perform worse than injectable drugs on measures of heart safety in the key studies supporting its application. There are still concerns, however. An editorial published in the New England Journal of Medicine alongside GSKs two large studies flagged the risk of cancer, and questioned the drugs benefit in patients who arent on dialysis, a group that makes up the majority of people with chronic kidney disease.

People with the wet form of age-related macular degeneration, a leading cause of vision loss, have many effective treatment options. The estimated 5 million people across the globe with geographic atrophy an irreversible eye disease that results from AMD dont. That could change if the FDA approves Apellis Pharmaceuticals pegcetacoplan later this year, however.

Pegcetacoplan is an injectable drug that blocks activation of the complement system, a part of the bodys innate immune response. In clinical testing, its shown the potential to slow growth of the lesions, or scar tissue, found in the eyes of people with geographic atrophy.

Yet Apellis doesnt have a clear-cut case. The drug missed statistical significance in one of its two Phase 3 studies. Apellis also hasnt yet proven that slowing lesion growth directly translates to improved vision. In August, the company reported patients in its late-stage trials didnt experience a visual acuity benefit after two years of treatment.

Apellis executives have expressed confidence the drugs benefit will become apparent with longer follow-up. We have trouble imagining a scenario where lesion size doesnt inevitably correlate with function, wrote Evercore ISI analyst Umer Raffat, in a research note.

A green light from the FDA could yield a drug that Jefferies analysts estimate could generate as much as $6 billion in yearly sales at its peak. A rejection or delay, meanwhile, could cost Apellis a chance to be first to market, as Iveric Bio plans to file for approval of a similar drug early next year.

The FDA will make a decision by Nov. 26.

For three years, analysts and investors have debated whether a cancer drug developed by Mirati Therapeutics, a small San Diego biotech, can top a rival one from Amgen that's become the crown jewel of the larger company's oncology business.

The two companies have traded clinical trial readouts showing their drugs can effectively shrink tumors driven to growth by mutations in a gene, called KRAS, that for decades was considered undruggable. Last spring, Amgen turned its positive data into a first-of-its-kind approval for its drug, now sold as Lumakras.

Now it's Mirati's turn in front of the FDA, as its drug adagrasib is under review with a decision deadline of Dec. 14. Should it win approval, Mirati would compete for market share with Amgen, which has the benefit of recent data confirming its drug beat chemotherapy in a larger study of patients with non-small cell lung cancer.

But Lumakras failed to show it could extend patients lives, leaving an opening for Mirati to do better. The company is currently enrolling a bigger trial that's meant to confirm adagrasib's benefit.

By Dec. 27, Gilead Sciences should know whether its second attempt at getting a key HIV drug approved in the U.S. has succeeded.

The first try ended with an FDA rejection because of concerns about potential adverse interactions between the drug, known as lenacapavir, and the specific glass vials in which it was contained. Gilead said it has since addressed those manufacturing-related issues by using vials made from a different glass. The treatment won its first approval in Europe in September.

A similar outcome in the U.S. would bolster the commercial prospects for an important addition to Gileads arsenal of HIV medicines. Lenacapavir has a unique way of binding to the protein shell that surrounds the virus, and its benefits appear long-lasting. In a small study, an injection of the drug every six months, in combination with other antivirals, kept the virus in check for heavily pretreated patients who had developed resistance to multiple therapies.

Gilead has been evaluating potential combinations of lenacapavir and other drugs, including Merck & Co.s islatravir, although that latter therapy has raised safety concerns over the last year. Gilead is also testing whether its drug works as a preventive treatment.

In a note to clients earlier this year, RBC Capital Markets analyst Brian Abrahams wrote that his team expects the FDA to approve lenacapavir for heavily pretreated HIV patients a relatively small indication that could generate peak annual sales of about $200 million in the U.S.

But given lenacapavirs various advantages, including the ability to be combined with other treatments and administered in multiple ways, the RBC team argues the drug could become the backbone of Gileads HIV franchise within several years and ultimately achieve more than $4 billion in yearly sales at its apex.

Will lecanemab, an experimental Alzheimer's drug that succeeded in a large clinical trial last week, become a backbone therapy for the neurodegenerative disease? Doctors and researchers aren't yet sure, as only limited data have been disclosed by lecanemab's developers, Eisai and Biogen.

They'll get much more information Nov. 29, when the companies present fuller study results at a medical meeting in San Francisco. The results are likely to be pored over and debated, as they represent the first clearly positive data from a Phase 3 trial of a drug meant to treat Alzheimer's underlying cause.

Theyre also likely to help the FDA decide whether to approve lecanemab on an accelerated basis. Using data from an earlier study, Eisai filed an application earlier this year, and a decision is expected by Jan. 6 on the basis of the treatments ability to clear toxic plaques from the brain.

The new trial results were meant to confirm those preliminary findings. Now that theyre positive, Eisai has a stronger case and the FDA a potentially easier judgment call.

See the article here:
5 FDA decisions to watch in the fourth quarter - BioPharma Dive

Posted in Cell Medicine | Comments Off on 5 FDA decisions to watch in the fourth quarter – BioPharma Dive

bit.bio Adds Two New Human Cell Products to Address the Translation Gap and Accelerate Research and Drug Discovery for Neurodegenerative Disease -…

Posted: October 4, 2022 at 1:42 am

CAMBRIDGE, England--(BUSINESS WIRE)--Cell coding company bit.bio has announced an expansion to its product portfolio - ioGlutamatergic Neurons TDP-43M337V disease model and early access to its ioMicroglia cell product.

Despite considerable research efforts and funding, the development of therapies for devastating diseases like Alzheimers disease (AD), Frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS) has been challenging. Due to a lack of standardised, easy to use and readily accessible human cell models, scientists have relied on animal models and cell lines that differ considerably from human biology.

bit.bios latest cell products provide a scalable source of human cells and will enable scientists to study neurodegenerative diseases in a human context. With consistency across batches and a scalable supply, bit.bios products will significantly reduce experimental variability in non-clinical studies and improve the translatability and reproducibility of research findings. These unique product features have the potential to transform research and drug discovery.

Dr Mark Kotter, CEO and Founder of bit.bio said:

The products we are announcing today address an area of high unmet clinical need where high failure rates in drug development are common and no effective treatments exist. I look forward to seeing how our customers will use them to develop new insights and treatments for these devastating conditions.

This is another step towards our vision of an exciting future in which precision reprogrammed human cells will accelerate biomedical innovation and a new generation of cures. The launch of two new cell products for research and drug discovery in neurodegenerative diseases validates our cell identity coding platforms ability to create and manufacture any human cell type consistently at scale.

Today, AD and FTD, the leading causes of early onset dementia, have no treatment options to stop or slow their onset. Similarly, current treatment options for ALS, the most common motor neuron degenerative disease, are limited. ioGlutamatergic Neurons TDP-43M337V, have a mutation in the TAR DNA binding protein gene that codes for the TDP-43 protein, which is known to cause both FTD and ALS. The disease model cells and the genetically matched control, ioGlutamatergic Neurons, mature rapidly, are highly reproducible between batches, and have unprecedented scalability. These key features make them ideally suited to high-throughput screening applications for early drug discovery. Being able to compare data from the physiologically-relevant disease models to those of the control offers the potential to identify and investigate the effects of the genetic mutation on the disease mechanisms of FTD and ALS.

Increasing evidence suggests that microglia contribute to the onset and progression of AD and are involved in the pathogenesis of ALS and FTD. Therefore they may represent an additional therapeutic target. However, speed, variability, and scalability continue to be major challenges with commonly used microglia. ioMicroglia, now available as part of an early access program, address these challenges allowing scientists to work with consistent, functional cells that are ready for experimentation within just 10 days.

Dr Farah Patell-Socha, VP Research Products at bit.bio, said:

Human cells are key to disease research, drug discovery, and clinical translation. However, traditional methods of producing human cells have long, laborious, protocols that often result in heterogenous cell populations and can lead to data variability. Our latest products provide robust, standardised tools for neurodegenerative research and drug discovery, paving the way for high-throughput screening and drug target validation in human iPSC-derived models that was previously impossible, and bringing huge benefits to medicine as a result.

The latest disease models are now available to order on the bit.bio website

Scientists can register interest in early access ioMicroglia vials, and find full physiological data on the bit.bio website

Notes to editors

About bit.bio

bit.bio is a synthetic biology company providing human cells for research, drug discovery and cell therapy. It has released six ioCells research products into the market and is currently building out its clinical pipeline.

bit.bios foundational opti-oxTM precision reprogramming technology enables highly consistent and scalable manufacture of human cells. The activation of cell type-defining transcription factor programs inserted into genomic safe harbour sites allows deterministic reprogramming of induced pluripotent stem cells (iPSC) into highly defined and mature human cells. bit.bios discovery platform is based on a deep synthetic biology tech stack and uses large scale experimentation and machine learning to identify combinations of transcription factor genes that encode cell identity.

bit.bio has assembled a team of pioneers with world-leading expertise in stem cell and synthetic biology, manufacturing, and clinical translation. The board is chaired by serial entrepreneur Dr Hermann Hauser and includes Sir Gregory Winter (Nobel Prize for Medicine) and biotech veteran Alan Roemer (co-founder Roivant and Pharmasset).

The company was spun out of the University of Cambridge in 2016. It is at Series B stage and has raised a total of $200M capital from Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, and Puhua Capital, and others.

For more information visit bit.bio

About ioMicroglia

ioMicroglia are iPSC-derived (induced pluripotent stem cell) immune cells, which will boost research into the physiology and diseases of the central nervous system, such as Alzheimers disease, Parkinsons disease and ALS.

ioMicroglia joins a growing portfolio of stem-cell derived human cells available from bit.bio, with the goal of empowering biomedical innovation towards a new generation of cures through precision reprogramming of human iPSCs. Microglia are immune cells which act as the first line of defence for the central nervous system, from both external and internal threats, and are a key research target when investigating immunological mechanisms in the brain. They are also key in supporting drug discovery into the modulation of microglia activation which can be used as a potential preventative strategy for Alzheimers disease.

The key advantage of ioMicroglia is that it addresses two of the major challenges encountered with commonly used human iPSC-derived microglia production protocols: namely speed and variability. ioMicroglia allows scientists to work with functional microglia that are ready for experimentation within 10 days versus 8-10 weeks with classical differentiation protocols. Moreover, ioMicroglia show high batch-to-batch consistency in morphology, key marker expression and functionality, in contrast to classical differentiation protocols.

ioMicroglia show key functional and phenotypic traits in culture including expression of TMEM119, P2RY12, and IBA1, and the ability to phagocytose invasive microorganisms, apoptotic cells or amyloid beta peptides associated with Alzheimers disease. Inflammatory properties are also maintained in bit.bios cells, further widening the potential applications of their use in translatable laboratory research. The ioMicroglia cells can also be co-cultured with bit.bios ioGlutamatergic Neurons whilst retaining microglial functionality, in order to recreate physiological conditions present in the central nervous system.

The new ioMicroglia cells are produced using bit.bios opti-ox platform which has once again proved its effectiveness in manufacturing physiologically relevant, consistent and reproducible cells at scale in a matter of days. Alongside bit.bios existing catalogue of cell types, ioMicroglia are a hugely useful resource for researchers investigating neurodegenerative disease.

About the TDP-43 disease models

Following the launch of its Huntingtons disease model earlier in 2022, ioGlutamatergic Neurons TDP-43 M337V/WT and ioGlutamatergic Neurons TDP-43 M337V/M337V are the second and third products in the companys ioDisease Model portfolio. The ioDisease Model cells take advantage of precision cell reprogramming and CRISPR/Cas9 genetic engineering, to produce highly characterised human induced pluripotent stem cell (hiPSCs)-derived excitatory neurons with disease-relevant mutations..

Frontotemporal dementia (FTD) is the second leading cause of early onset dementia following Alzheimer's disease. It involves atrophy of the frontal and temporal regions of the brain affecting language, memory, and behaviour. Amyotrophic lateral sclerosis (ALS) is the most common motor neuron degenerative disease and is characterised by progressive degeneration of both upper and lower motor neurons.

The disease models are engineered with a disease-relevant M337V mutation in the TARDBP gene, which codes for the TAR DNA-binding protein 43 (TDP-43). This mutation in the TDP-43 protein promotes cytoplasmic mislocalisation and aggregation, which is implicated in the pathology of ALS and FTD. These disease models offer a fast and easy-to-use system for investigations into the impact of gene function on disease progression. One of the key advantages is the availability of a genetically matched control, which enables researchers to make true comparisons as they can attribute observed differences to the single genetic modification.

Excerpt from:
bit.bio Adds Two New Human Cell Products to Address the Translation Gap and Accelerate Research and Drug Discovery for Neurodegenerative Disease -...

Posted in Cell Medicine | Comments Off on bit.bio Adds Two New Human Cell Products to Address the Translation Gap and Accelerate Research and Drug Discovery for Neurodegenerative Disease -…

Laser Focus World highlights UC research that uses light to restore cell function – University of Cincinnati

Posted: October 4, 2022 at 1:42 am

Laser Focus World magazine recently highlighted University of Cincinnati research in its weekly "Photonics Hot List" YouTube show.

The show highlighted recently published research out of the lab of UC's Jiajie Diao, PhD, that shows early indications that light can be used as a treatment for certain diseases, including cancer.

Hundreds of mitochondria are constantly coming together (a process called fusion) and dividing into smaller parts (a process called fission) to stay balanced in healthy cells. But when mitochondria are not functioning properly, there is an imbalance of this process of fission and fusion, which can lead to a number of mitochondrial diseases, including neurodegenerative diseases like dementia and certain cancers.

The researchers used light to activate proteins that bring together parts of the cell to achieve mitochondrial fission, helping to bring cells back into balance.

We found that it can recover the mitochondrial function, said Diao, associate professor in the Department of Cancer Biology in UCs College of Medicine and a University of Cincinnati Cancer Center member. Some of the cells can even go back to normal. This proves that by just using some simple light stimulation we can at least partially recover the mitochondrial function of the cell.

Watch the Photonics Hot List segment. (Note: Segment begins around 2:51 mark.)

Read more about Diao's research.

Featured photo at top of Jiajie Diao working in his lab. Photo/Colleen Kelley/UC Marketing + Brand.

Read this article:
Laser Focus World highlights UC research that uses light to restore cell function - University of Cincinnati

Posted in Cell Medicine | Comments Off on Laser Focus World highlights UC research that uses light to restore cell function – University of Cincinnati

SPECIAL REPORT: Bioengineered food labeling: ‘They kind of shot in the middle and missed every constituency’ – FoodNavigator-USA.com

Posted: September 25, 2022 at 2:49 am

The NationalBioengineeredFood Disclosure Standard(NBFDS) which narrowlydefines bioengineered foods as those that contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature kind of shot in the middle and missed every constituency,"observes Nate Ensrud, VP, US technical services, certification, and food safety solutionsatFoodChain ID, which helps firms to comply with the standard.

For some stakeholders in the natural foods industry, he says,it missed the mark,both in scope (the definition fails to capture thousands of products that have been produced with genetic engineering) and application (many objected to bioengineered vs GMO as the chosen terminology and the option to use digital disclosures on food labels).

For other stakeholders who believeslapping a blanket statement about bioengineering (which has thousands of different applications) on a jar of pasta sauce is about as useful as saying 'science was used to make this product," the NBFDS in its current form is just acostlybureaucratic headachewithout any obvious consumer benefit.

A major sticking point is the definitionof bioengineered, which excludes meat and dairy from animals fed GM feed, incidental additives, and highly refined oils and sweeteners made from GM crops such as soybean oil and high fructose corn syrup if they contain no detectable modified DNA.

Gene-edited foods, in turn, occupy something of a grey area. They may not contain detectable genetic material that has been modified through traditional rDNA techniques, but how easy is it for a third party to determine if gene-edited material meets the definition ofcannot be created through conventional breeding or found in nature?

Back in the day, says Ensrud, We were mostly talking about a series of crops that very obviously had genes inserted to express different traits.

"But since then, theres been a substantial proliferation of gene-edited products, products made using synthetic biology and so on, and while the [alternative meat, egg, and dairy]movement used to be pretty aligned, this is not the case anymore [as anyone following the social media debate about whether 'biotech' companies should be allowed to exhibit at Natural Products Expo West can see].

For example, under the NBFDS, firms deployingsynthetic biologyto re-tool the DNA of microbes to produce everything from flavors, sweeteners, and colors to animal-free collagen, egg, or dairy proteins are not required to label their ingredients as 'bioengineered' if there is no detectable level of the genetically modified host micro-organism in the final product.

This means that milk, ice cream, or cream cheese containing Perfect Days animal-free whey protein, which is expressed by a genetically engineered strain of fungi in a fermentation tank; or beverages containing Cargills EverSweet Reb M sweetener, made by GM bakers yeast, will not trigger a bioengineered label, if no GM material is detectable in the final ingredient.

However, burgers containing Motif FoodWorks 'meaty' animal-free heme protein myoglobin which is also made in a fermentation tank using a pichia pastoris yeast strain probably will trigger a bioengineered disclosure under the NBFDS, as trace amounts of the host microbe may be in the final product, says the company.

But even for exactly the same ingredient - myoglobin - no two companies producing this via fermentation are necessarily subject to the same labeling requirements when it comes to bioengineered food, saysBelgian startup Paleo, which has engineered a strain of pichia pastoristo express myoglobin in an extra-cellular fashion (it's secreted outside the cell).

This means its easier to separate myoglobin from the yeast cells during downstream processing and purification, such that Paleo'smyoglobin would not trigger bioengineered labeling in the US and would not be subject to EU GMO regulations, argues co-founder Hermes Sanctorum.

"Weve tested our heme proteins through PCR and there is no recombinant DNA whatsoever in our products.

The difficulty for companies trying to navigate this minefield is that the NBFDS doesn't really talk much about microbes"or much less explain how you label them with the exception of something like certain probiotics where genetically engineered bacteria might be the end product itself [rather than a production platform for something else], notes Ensrud.

To further complicate matters, he says:Then theres a really vague section of the of NBFDS that says if a company has actual knowledge its using something bioengineered, even if a food is not on the BE list, it is supposed to make a disclosure, which feels like a throwaway line, but how do you determine that?

He adds:We don't know a lot about how this will be enforced because the USDA has been clear that they're not going to be proactively enforcing this, but will be reliant on complaints. And so far, we havent seen very many well-structured complaints that can help us say, these are the areas that companies are going to challenge, and I don't know that it's going to be one of the first areas people think about because microbes are not included in the list of bioengineered foods.

(FoodNavigator-USA has asked USDA how manywritten complaints have been filed with the AMS Administrator alleging violations of the NBFDS and will update this article when we hear back.)

The detectability factor makes practical sense, argue many stakeholders: if there's noGMOactually in the food, why should you have to label it?

But for organizations such as the Non-GMO Project that take issue withgenetic engineering in the food supply chain per se, whether there's actually any 'modified genetic material' left in soybean oil or a natural flavor is hardly the point, notes Ensrud.

Their goal is to establish a GMO-free supply chain, and so the gap between their definition of what should be labeled GMO and the NBFDS is an ocean wide.

Having said that, the Non-GMO Project has arguably gained traction as a result of all this confusion, given that foods without bioengineered labels are not necessarily Non-GMO given the narrow scope of the federal law, prompting shoppers that care about avoiding genetic engineering to seek outthe butterfly logo while shopping if they want to be sure.

So what about disclosure options, which like everything else in theNBFDS, have generated a lot of controversy? The standardpermits multiple options:

Aspects of the digital disclosure options have just been successfully challenged in a lawsuitbrought by the Center for Food Safety and others, with a court sending USDA back to the drawing board to make revisions consistent with Congressional requirements around consumer access.

So what does this mean for companies currently using the QR code or text message option? According to Ensrud, We did see some companies choose to use the QR code, but not a large majority by any means. The ones that were choosing QR codes told us they liked the flexibility, as perhaps they were still trying to remove some bioengineered foods from their supply chain and would move from having to disclose to not having to disclose, which would require a change in labels, which can be costly and laborious.

The opposite is also possible. If a company has to make an emergency shift from a non-GMO source to a GMO source for an ingredient [not that unusual given current supply chain volatility], it would likely change the labeling requirements. For companies that have less settled supply chains, this change in requirements could make things more difficult.

Sam Jockel, a senior associate at law firm Alston & Bird, noted that There is still an opportunity for either USDA or the plaintiffs in this case to appeal theruling, which I am watching for.

According to George Kimbrell, legal director at the Center for Food Safety, which filed the lawsuit challenging many aspects of the NBFDS, The Court did not set a deadline, but under law agencies cannot unduly delay such action and must complete it in a reasonable time.

Should the order ultimately stand, said Jockel,it appears that USDA would have discretion in terms of timing as the court did not set any deadlines for USDA to conduct its post-remand proceedings.

For those who think this means that the QR code will go away, added Jockel, The statute passed by Congress requires an electronic/digital link disclosure as one of the options along with the text and symbol, so the QR code option is not going away.

The Consumer Brands Association said it is still reviewing the court order, but added:"We plan to stay engaged during the forthcoming rulemaking and legal process, especially considering the potential impact on the companies using QR codes or texts. Consumer Brands will also continue supporting the valuable role digital disclosures play in boosting consumer transparency through programs like SmartLabel.

Jockel also noted that the scope of the products that require mandatory disclosure is actually subject to change.

Companies will want to watch for any updates to thelist of BE Foodsas AMS is required to review and consider updates on an annual basis. As the judges order put it in reference to the agencys regular updates to the List of BE Foods, AMS did not ignore the likelihood of progress. As evidence of that, the agency is currently proposing to expand the list to include insect-resistant sugarcane.

Greg Jaffe, biotechnology project director at the Center for Science in the Public Interest (CSPI), told us that an informal surveyconducted in his local Giant grocery store earlier in the year found that almost no companies use the symbol on the package with most seeming to opt for the bioengineered food or contains a bioengineered food ingredient option, although several brands had adopted QR codes.

My informal survey also found many foods disclose even though they probably only have highly refined ingredients, so companies are clearly erring on the side of giving more information to the consumer than might be required.

So has the law helped consumers make informed choices? Or are blanket references to bioengineered foods just wallpaper to busy shoppers?

I think that the law has provided consumers who want to know this information, more information than they would receive without the law, said Jaffe, who described it as a step in the right direction in terms of transparency, in part because companies were not providing this information voluntarily anywhere for the consumer who wanted it.

He added:I dont think many consumers look for this information or make purchasing choices based on it. With that said, for many consumers, knowing that there is transparency and information is available is important (i.e. knowing that information that some people might want is not hidden or inaccessible).

Asked about the growing number of ingredients produced by genetically engineered microbes, he said:Many ingredients made with engineered organisms also will not require disclosure, but I think it is important that those companies are transparent and provide information to consumers about the origin of the ingredients in their products, whether or not it has to be disclosed as bioengineered.

Being transparent with consumers will build trust, educate consumers about the use of biotechnology in foods, and allow for consumer choice.

Further reading:

Read the original here:
SPECIAL REPORT: Bioengineered food labeling: 'They kind of shot in the middle and missed every constituency' - FoodNavigator-USA.com

Posted in Genetic Engineering | Comments Off on SPECIAL REPORT: Bioengineered food labeling: ‘They kind of shot in the middle and missed every constituency’ – FoodNavigator-USA.com

Synthetic biology has the power to cure and kill. How will we use it? – Big Think

Posted: September 25, 2022 at 2:49 am

The prospect of creating life in the laboratory is as fascinating as it is terrifying. Will we really be able to modify the genetic code of a living creature to mold it to our design? Will we be able to assemble different bits of living creatures to create a new one?

A few years back, J. Craig Venter announced the creation of a living, self-reproducing bacterial cell with a DNA sequence produced in the laboratory. According to Laurie Garretts 2013 article for Foreign Affairs about this experiment, the creature moved, ate, breathed, and replicated itself. Garrett quotes from an older interview with Venter from 2009: Theres not a single aspect of human life that doesnt have the potential to be totally transformed by these technologies in the future.

These technologies refer to the world of synthetic biology, the ability to construct living creatures from the assembly of different parts in a sort of Lego world of the living. Playing the game of life is no longer the stuff of sci-fi stories. If you need further proof, I refer you to the Big Think video featuring Nobel Prize-winner Jennifer Doudna (as well as a recent interview), exploring the universe of CRISPR technology the good and the bad of it. Also, check out the excellent Netflix documentary series Unnatural Selection.

The question, as this technology evolves, becomes one of regulation and control. As Richard Lewontin asked in his essay on synthetic biology for The New York Review of Books, In cases where there is a conflict between the immediate and the long-range consequences or between the public and private good, how can that conflict be resolved?

The difference between the gothic speculations of Mary Shelleys Frankenstein and todays reality is twofold: First, we are building these creatures fiction is now real. Second, money plays a huge role in it. There is great financial gain in genetic engineering, an industry that according to estimates offered by Drew Endy from Stanford Universitys bioengineering department, contributes two percent of the U.S. economy and is growing at a pace of 12 percent each year.

The problem, as Lewontin reminds us, is that we often cannot rely on those who pursue invention for profit or for military interests to have the publics best interest in mind. So, as we create new lifeforms for different purposes, who will control them? The stockholders of biotech companies? The government? How will we reach a consensus on such a divisive topic that has clear global reach?

Subscribe for counterintuitive, surprising, and impactful stories delivered to your inbox every Thursday

The stakes are so high, and discussion must be brought into the open. There are great possibilities and great dangers. There is money to be made and cures to be found. There are horrible weapons and potential environmental chaos, too. The biosphere is a complex network of unpredictable interactions and responses that affect us and every other voiceless creature on this planet. Collectively as the human species, we must have some control over where all this is going. But how?

The opinions of scientists matter, of course. Corporate accountability and manufacturer liability are certainly reasonable. And there also should be democratic participation and transparency. We are all stakeholders in this debate.

All sorts of questions come into the open, questions that we should already be thinking about very seriously. Years have passed since this started, and there hasnt been much progress on addressing those questions. Synthetic creations such as genetically modified organisms (GMOs) are widely available, and a growing number of people are eating them. As far as science is concerned, there is no reason for us not to. (It is telling that so much conflict goes into the commercial labeling of such products, so that people actually know what they are consuming.)

How could we enforce the full public participation? How can we guarantee that different sectors of the population in this and other countries know enough about the various issues to reach a well-informed opinion? Some of the issues involved are extremely technical, and even the experts disagree on the details, as is the case with most cutting-edge research. How can we guarantee that government legislators are free of party bias or lobbying influences as they decide how to rule on the matter? Will the health and social benefits from the technology outpace its potential dangers?

Governments will face internal conflict, as they need to protect their citizens, defending them from any enemy that might use synthetic bioweapons. They may, of course, manufacture the weapons as well, perhaps mirroring the nuclear dtente policy of Mutually Assured Destruction: If you attack me, I attack you, and we both die. Very safe policy indeed, and very morally advanced.

If such technologies are used in wars or terrorist attacks, how efficiently will we be able to isolate from them? Judging from the responses to the COVID pandemic, government efficiency leaves much to be desired. Unless you plant your own organic garden and live in some sort of ecologically insulated bubble, synthetic biology will be knocking at your door. The question, then, is whether it will usher in a new era for humanity, or end up as the latest example of a promising technology that is used to inflict pain and destruction. Such technologies have emerged from physics (nuclear bombs) and from chemistry (poison gas). Now that its biologys turn, hopefully our past experiences have made us wiser.Hopefully we know better, now.

Read the original post:
Synthetic biology has the power to cure and kill. How will we use it? - Big Think

Posted in Genetic Engineering | Comments Off on Synthetic biology has the power to cure and kill. How will we use it? – Big Think

September 23, 2022: The Integrity of Marius Mason WFHB – WFHB News

Posted: September 25, 2022 at 2:49 am

Podcast: Play in new window | Download (Duration: 29:00 39.9MB)

Subscribe: RSS

This week, we share the second part of a recorded discussion hosted by the Civil Liberties Defense Center. CLDC has been at the forefront of anti-repression legal work for decades now, working on many of the Green Scare cases, in which the FBI infamously hounded and smashed radical environmental organizing between 2000 and 2008. In this discussion, Chava and Lauren speak with Letha, a long-time supporter for Marius Mason, who is the last remaining Green Scare prisoner. Marius is a former Bloomington resident whose public organizing and clandestine acts of sabotage in the 1990s presaged many of the ecological concerns which have now become global issues as we face climate catastrophe. Marius was harshly sentenced to almost 23 years in prison for acts of sabotage against logging, highway construction, water privatization schemes, and corporate genetic engineering. He came out as a trans man while inside and is being held at the federal prison in Connecticut.

Thanks to theCLDCfor organizing this important discussion and for all their work.

You can find out more about how to support Marius here:https://supportmariusmason.org/

Here are some of our favorite previous episodes about Marius:

Last Weeks Episode: https://www.kitelineradio.org/podcast/321-marius-mason-the-last-green-scare-prisoner/

8 | Dear Marius

45 | Ongoing Support for Marius Mason and His Family

150 | Be Like Water: J11 Reflections on Marius Mason’s Journey Through Federal Prison

Continue reading here:
September 23, 2022: The Integrity of Marius Mason WFHB - WFHB News

Posted in Genetic Engineering | Comments Off on September 23, 2022: The Integrity of Marius Mason WFHB – WFHB News

Yeast-Fermented Chemo: Now We Can Brew Anything – Medscape

Posted: September 25, 2022 at 2:49 am

An incredibly old way of making drugs is now an incredible new way to make drugs. Scientists have genetically reengineered a yeast fermentation process in order to produce chemotherapeutics instead of beer.

Vinblastine is the most complex compound produced with engineered yeast so far, the researchers say. Its naturally occurring ingredients are normally harvested from an endangered plant in Madagascar, and the chemotherapeutic is on the World Health Organization's essential medications list. Synthetic production of vinblastine could eliminate supply problems, lower costs, and save lives.

Getting it right took 7 years.

"It's like getting an orchestra to play in tune, because all of those steps have to work together in order to get to that final product," said article co-author Jay Keasling, PhD. "If you feed yeast sugar, it produces beer and wine. In this case, we've replaced the ethanol pathway with pathways to produce these natural products."

Genetically engineered yeast (along with E coli) is a key microorganism used in biopharmaceutical production. Yeast has been redesigned to produce other naturally occurring compounds, such as cannabinoids and the antimalarial drug artemisinin. The process involves removing a sequence of biochemical reactions, or metabolic pathway, from a plant cell and reconstructing it inside a yeast cell.

Vinblastine is part of a family of more than 3000 plant-produced molecules called monoterpene indole alkaloids (MIAs), several of which have been approved by the US Food and Drug Administration as therapeutics. Each MIA comes from a different plant, some of which are rare or in danger of extinction from overharvesting, according to Keasling.

"Engineering a yeast to produce these molecules would enable their production in a simple platform, fermentation, rather than having to grow individual plants or harvest them from the wild," explained Keasling. "We've essentially co-opted this age-old method for producing beer and wine to produce these other important products."

The international team of researchers, led by the Technical University of Denmark in Kongens Lyngby, Denmark, wanted to prove that they could synthetically manufacture all kinds of MIAs, so they started with the most complex one they knew of: vinblastine.

Vinblastine has something like 30,000 genes. The researchers first had to identify a 31-step sequence. It is the longest biosynthetic pathway ever removed from a plant and inserted into a microbe, according to the researchers.

Until now, vinblastine could only be produced by using two active ingredients, vindoline and catharanthine, harvested from the leaves of the Madagascar periwinkle plant. It can take more than 4000 pounds of dried leaves to produce a single gram of vinblastine. Supply delays resulted in an international shortage of the drug from the summer of 2019 until 2021.

Although the researchers couldn't produce vinblastine directly in yeast, they succeeded in genetically engineering yeast to produce vindoline and catharanthine. These compounds were then purified and coupled chemically to form vinblastine.

Reconstructing vinblastine's metabolic pathway required 56 genetic edits, according to the researchers. Biochemical reactions that occur at each step along the pathway require enzymes so the researchers had to ensure that enzymes were produced in the correct amount.

"You can't have one step working significantly better than all the other steps, or one step that doesn't work very well at all," said Keasling. The enzymes also depend on other factors, such as vitamins and minerals, which also had to be inserted into the sequence.

The researchers produced only a very small amount of vinblastine, but the technique opens the door for production of numerous other naturally occurring compounds, including an antiaddiction molecule that's expensive to manufacture because it's produced by plants in small quantities.

"This molecule we chose is kind of like a holy grail. It's a big molecule, it's really challenging to produce in any other way," Keasling said. "And so, if we can do this molecule, that means that the other ones are definitely doable."

Funding for the research was provided by the National Institutes of Health, the European Research Council, the Wellcome Trust, the Open Philanthropy/Silicon Valley Community Foundation, the Weston Havens Foundation, and the Centre for Trophoblast Research.

Nature. Published August 31, 2022. Full text

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

See the original post:
Yeast-Fermented Chemo: Now We Can Brew Anything - Medscape

Posted in Genetic Engineering | Comments Off on Yeast-Fermented Chemo: Now We Can Brew Anything – Medscape

Bananas threatened by devastating fungus given temporary resistance – New Scientist

Posted: September 25, 2022 at 2:49 am

A way to make Cavendish banana plants temporarily resistant to Fusarium fungus could lead to new ways to protect them from Panama disease

By Michael Le Page

Bananas are at risk from a fungal disease

Ezequiel Ferreira/EyeEm/Getty Images

Banana plants that produce the worlds most widely eaten variety of the fruit have been made temporarily resistant to a devastating fungal disease that is spreading around the world and destroying plantations. The hope is that the work could lead to ways to make bananas permanently resistant.

The question is, can we continuously trigger this mechanism? says Gert Kema at Wageningen University in the Netherlands. We need to know more about it.

The main banana exported to Western countries used to be a variety called Gros Michel. But in the 1920s, a strain of Fusarium fungus called tropical race 1 (TR1), which causes Panama disease, began wiping out plantations in banana-producing areas. By the late 1950s, growers had switched to the Cavendish banana, which isnt as tasty as the Gros Michel, but is highly resistant to TR1.

Now, however, another strain of Fusarium called TR4 that can kill many varieties, including the Cavendish, is spreading to more and more countries. In many places bananas are a staple crop, so this fungus is a threat to food security as well as livelihoods.

Kema and his colleagues wondered if exposure to TR1 would protect Cavendish bananas against TR4. The team uprooted young plants and dunked them in a solution containing assorted types of TR1 fungus. At various time intervals from 30 minutes to 10 days later, they then immersed plants in a solution with spores of TR4 in it.

The team found that prior exposure to a particular strain of TR1 from Brazil provided significant protection against TR4 up to 10 days later.

Somehow you are switching on a protective mechanism that also protects plants from TR4, says Kema. But the protection is only temporary.

This kind of protective effect has been found in other plant species before, he says. Plants dont have immune cells that remember pathogens like animals do, so the effect is the result of switching on general protective mechanisms rather than specific ones that result from a vaccine. The team is now trying to work out the precise mechanisms in bananas, with the aim of finding ways to permanently turn them on without exposing plants to a live fungal disease.

Even if it can be done, this, or other approaches such as genetic engineering, wont solve all the industrys problems, says Kema, not least because TR4 is far from the only disease affecting bananas.

The main issue is the worlds heavy reliance on a single variety of the fruit, he says. Cavendish accounts for more than half of all bananas grown and 95 per cent of exports. Because the Cavendish is sterile like most edible bananas, all Cavendish bananas are genetically identical clones. All this makes plantations especially vulnerable to diseases.

Diversification is crucial, says Kema. The banana industry needs to invest in developing new varieties that are both tasty and disease-resistant, supermarkets need to stock them and consumers need to buy them. Banana production at this point in time is not sustainable, says Kema.

Journal reference: PLoS One, DOI: 10.1371/journal.pone.0273335

More on these topics:

See the rest here:
Bananas threatened by devastating fungus given temporary resistance - New Scientist

Posted in Genetic Engineering | Comments Off on Bananas threatened by devastating fungus given temporary resistance – New Scientist

2 Risky Cathie Wood Growth Stocks to Buy and Hold for 5 Years – The Motley Fool

Posted: September 25, 2022 at 2:49 am

Portfolio manager Cathie Wood is known for having an aggressive appetite for risk when it comes to the investments she makes in her exchange-traded fund, the ARK Innovation ETF (ARKK -2.02%). Between its stakes in biotech companies with no products on the market and in rising stars like Tesla, its holdings are often in long shots that have the potential to be transformative for their industries or for the world.

On that note, there are two promising -- but speculative -- biotechnology businesses in the ARK portfolio that investors might be interested in if they're patient enough to hold onto their shares for a few years before seeing major returns. Over the next five years, Wood's thesis for both will be tested, so people who buy shares now could join in her eventual profits -- or her losses, which have been substantial for both stocks over the last 12 months.

CRISPR Therapeutics (CRSP -2.68%) is a gene-editing biotech that is working to develop cures for hereditary conditions including sickle cell disease and beta-thalassemia. Before the end of 2022, it expects to ask regulators at the Food and Drug Administration to approve the gene therapy exa-cel, which it claims can functionally cure both diseases. That means sometime in 2023, it could be realizing revenue from sales of its treatments for the first time ever, which will be a major catalyst for the stock.

But CRISPR's true potential actually lies beyond exa-cel. It's also investigating a handful of candidates as off-the-shelf immunotherapies that could treat different cancers, among them lymphoma. The off-the-shelf aspect is what differentiates these programs from the immunotherapies in development by most other companies, and it's also the most exciting thing about CRISPR.

A common problem with sophisticated cell therapies made using genetic engineering is that the patient's body may reject the cell therapy upon infusion. To get around that issue, biopharmas use each patient's own cells as the starting material to manufacture their specific therapy. That's effective, but it's also tremendously expensive because of the costs involved with drawing a sample, shipping it to a manufacturing site, processing it to make a single person's therapy, and then shipping it back to be infused into the patient.

What CRISPR hopes to do is produce non-personalized immunotherapies that don't trigger rejection. If it succeeds, its treatments will be far more scalable to manufacture, far more profitable to sell, and maybe even more effective than those produced by its competitors. That possibility is exactly what Wood is betting on with her investment, but it's almost certain to take a bit longer than a year or two to come to fruition because of how ambitious the goal is.

If you're willing to take a risk that CRISPR won't ever be able to figure it out for the chances of outsized rewards if it does, this is a good stock to buy.

Intellia Therapeutics (NTLA -5.54%) also plans to use advanced gene-editing techniques to treat people's genetic diseases. Like CRISPR Therapeutics, it doesn't have any revenue outside of what it makes from collaborations -- and that only totaled around $33 million in 2021. In terms of its pipeline, it has an early-stage program for sickle cell disease, and other early-stage programs aiming to address transthyretin amyloidosis, a rare hereditary liver disease.

Excitingly, its therapies for those conditions could be curative, though management is careful to remind investors that those treatments could still deliver much-needed relief to patients for long periods without being complete cures, technically speaking. But it isn't anywhere close to commercializing any of its therapies, so it's definitely a stock you'll need to hold onto for at least three or four years before it has the possibility of delivering major returns.

Furthermore, Intellia is developing capabilities similar to CRISPR's with regard to off-the-shelf immunotherapies, though CRISPR's are further advanced. It's pretty clear that Wood bought into Intellia to diversify her bet on easily scalable immunotherapies and give herself two opportunities to succeed. It might make sense for you to do the same if you're looking to hedge your other gene-editing stock plays.

Alex Carchidi has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends CRISPR Therapeutics, Intellia Therapeutics, and Tesla. The Motley Fool has a disclosure policy.

Read more:
2 Risky Cathie Wood Growth Stocks to Buy and Hold for 5 Years - The Motley Fool

Posted in Genetic Engineering | Comments Off on 2 Risky Cathie Wood Growth Stocks to Buy and Hold for 5 Years – The Motley Fool

‘What Hath God Wrought’ – Today, Luddites Are Concerned About Weedkillers Like They Once Were The Telegraph – Science 2.0

Posted: September 25, 2022 at 2:49 am

Do you believe the telegraph was giving telegraph operators cancer? If not, it's only because there was no Robert F. Kennedy Jr. or US Right To Know group promoting fear and doubt about it the way they do vaccines, food, and cell phones.

On May 24th, 1844 a telegram was sent from the Capitol because Samuel Morse, the inventor, wanted a government contract. Because he was diplomatic, he let the daughter of Henry Ellsworth, first Commissioner of the U.S. Patent Office, draft the message. And because young people need to Live In Important Times, the message proposed by young Annie was "What Hath God Wrought. (1)

There was fear. Fear of electricity in wires and its effect on humans, fear of rapid communication meaning more false claims making their way around the world - "Does it not render the popular mind too fast for the truth?" - and the paucity of thought telegrams required, like older people fear emojis that replace words in text messages. Humans have an evolutionary mandate to fear, nature is out to kill us and everything else, and science has always battled that fear the same way it has battled nature when it comes to disease and the elements and food.

While science and technology always fight for progress, there have also always been people who worried about that. Sometimes for good reasons. Early steam trains had to be tested using dogs because it was unclear if the human body could go 25 miles per hour for long periods of time without our organs being affected. Testing solved that and progress marched on. Yet in the modern era, where people act not out of public concern but because they are paid to promote fear and doubt, no amount of testing will help. A train would not get approved due to lawsuits and claims that such an evil FrankenHorse 'needs more testing.'(2)

Weedkillers like atrazine and glyphosate, and therefore farmers and shoppers, suffer due to such thinking now. Lacking any evidence of harm, activists and their carefully placed allies in epidemiology insist the harmful effects are real, scientists have just not found them yet. They embrace homeopathic beliefs like endocrine disruption and dream up stories of chemical cocktails. It is not just chemicals, being anti-biology is also wildly profitable. The Non-GMO Project is a financial juggernaut, but GMOs, the most recent form of genetic engineering on the market, have never harmed plant, human, or other animal in decades of use. Despite the science proving GMOs completely safe, Non-GMO Project sells stickers for nearly 70,000 products. There are only 11 GMOs on the market. To line their pockets anyway, they sell stickers for products like salt. Anti-science Luddites who buy their clients' products are so clueless they think salt is an organism with a gene that can be modified. Salt.(3)

To future generations, people who embrace this folklore and shamanism about agricultural progress are going to be derided the way we now look at old articles claiming that too many books were going to cause the brains of children and women to rot. Parents were told by the same kind of social authoritarian busybodies that now dominate states like California to worry if their children played outside too much.

It seems ridiculous(4) but so is the notion that a weedkiller which only acts on a biological pathway found in plants can cause human cancer. Or that a drop of a weedkiller in water equivalent to 160 Olympic-sized swimming pools will turn frogs 'gay', as famed weedkiller activist Professor Tyrone Hayes of Berkeley termed it. Or at least change their voices. Neither of which he ever showed data to prove.

He didn't need data, he had a group of professional protesters repeating the weedkiller equivalent of the claim that the telephone would create bad manners in those who used it.

People who fear progress never know how backward they look while claiming they see something scientists can't see. Yet young people of the future will.

NOTES:

(1) His effort failed, government did not fund it. Good thing too. After its failure to get government money, the private sector took over and put up 10,000 miles of line and communication took off. Had the government taken it on, we'd have a porkbarrel mess like cable television and solar power.

Issue changes, but young people still need to live in important times. American actor Timothe Chalamet is equally convinced the apocalypse is just around the corner and buying a ticket to his new film will make you feel better about that.

(2)The plight that holds back beneficial products like Golden Rice for poor countries - because it was a free effort by scientists, no company behind it, environmentalists easily blocked it with their own highly-paid attorneys.

(3) Meanwhile, mutagenesis, the less-precise precursor to GMOs, created when plants are dunked in chemicals and bathed in radiation to force mutations, is certified organic. Literally thousands of products are on the market, but since they already were before the anti-GMO craze took off (blame King Charles III)they get the fancy sticker sold to them by 80 companies in the US who stay in business by selling organic stickers.

(4) Writing in The Atlantic, Adrienne LaFrance details worries like that the telephone would make the left ears of people different than the right. Sound crazy? It actually sounds a lot like the many weird epigenetics claims we have had in the last 15 years. Epigenetics is a valuable tool for anti-science activists because it covers so much ground, literally any change due to anything, it can't be proved wrong.

See the original post here:
'What Hath God Wrought' - Today, Luddites Are Concerned About Weedkillers Like They Once Were The Telegraph - Science 2.0

Posted in Genetic Engineering | Comments Off on ‘What Hath God Wrought’ – Today, Luddites Are Concerned About Weedkillers Like They Once Were The Telegraph – Science 2.0

Page 191«..1020..190191192193..200210..»